The Ministry of Industry and Trade of the Russian Federation has proposed the introduction of a score-based system for assessing the level of production localization for certain medical devices and rehabilitation equipment. The corresponding draft government decree has been published for public consultation and concerns amendments to Government Resolution No. 719. The new rules provide for the allocation of scores to technological operations and materials, as well as the establishment of minimum annual localization thresholds. The system is expected to enter into force on 1 January 2026.

As noted by Baikal Communications Group, these changes may significantly impact manufacturers of medical devices, particularly prosthetic and orthopedic products, where the share of imported components currently reaches up to 60%. The introduction of the score-based system will create both new opportunities and additional operational burdens for businesses.

“On the one hand, the focus on import substitution policies gives domestic and locally-based manufacturers advantages within public procurement mechanisms and stimulates the development of local production. On the other hand, it is important to take into account that confirmation of the localization status must be renewed on a regular basis. Registry entries are valid for 3–5 years, requiring companies to undergo the verification procedure periodically,” Baikal Communications Group emphasized.

In addition, manufacturers are required to submit annual reports on produced and marketed products no later than 1 April. Failure to comply may result in removal of the product from the register. At the same time, localization criteria themselves are subject to frequent revision, creating uncertainty and requiring flexibility in the modernization of production processes.

“It is crucial that the new system be implemented with maximum consideration of sector-specific factors. Market participants who were not involved in preliminary discussions now have the opportunity to submit their proposals before the close of the public consultation on 25 November. Broad involvement of interested stakeholders will help minimize business costs and enhance the effectiveness of integrating the new localization model,” Baikal Communications Group noted.

It bears recalling that a similar score-based localization confirmation system for the pharmaceutical sector will also enter into force on 1 January 2026. Its objective is to stimulate the expansion of the range of medicinal products manufactured within the Russian Federation and to support the technological development of companies.

More details are available in Pharmvestnik

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